Plain English Summary

Current plain English summary as of 03/08/2018:Background and study aimsPsychosis is a mental health problem that causes people to perceive or interpret things differently from those around them. Common symptoms of psychosis are unusual beliefs (delusions) and hallucinations (most often, hearing voices). Antipsychotics are the standard medication for these problems and are often often helpful but can have serious side effects. There is also evidence that talking therapies (such as cognitive behaviour therapy (CBT) or family intervention) can help reduce symptoms and prevent relapse. The guidelines suggest that treatment options should include the possibility of choice between CBT, antipsychotic medication or both. However, more research is needed to see how well psychological treatment works when used alone, compared with antipsychotic medication and compared with psychological treatment and antipsychotic medication combined. The first stage to better understanding what is most helpful is to conduct a small study to see if young people and their families want to take part in this kind of research and to find out what they think of taking part. This will show whether a larger study should be done and the best way to do it.

Who can participate? Patients aged 14-18 diagnosed with psychosis

What does the study involve? Participants are randomly allocated to one of three groups. Participants in the first group are treated with psychological therapy, which involves up to 30 sessions of CBT plus 6 sessions of family intervention (this is optional). Participants in the second group are treated with antipsychotic medication prescribed by the participant’s own psychiatrist. Participants in the third group are treated with a combination of psychological therapy and antipsychotic medication. All participants are also asked to attend four research assessments and physical health checks: at the first visit, then at 3, 6 and 12 months after the first visit. Participants who are recruited into the study after February 2018 are not seen for a research assessment and physical health check at 12 months because of the study end date.

What are the possible benefits and risks of participating? Each participant benefits from access to one or more currently recommended treatments for psychosis. The likelihood of risk from the treatments is minimal. The investigators have considerable experience of the treatments and assessments used in this study and are not aware of any risks to participants. While the risks are minimal there may be a risk of side effects from antipsychotic medication. Although this is a standard treatment for young people with psychosis there are side effects from antipsychotics. To address this risk, the antipsychotic medication is prescribed by the participant’s psychiatrist, based in the care team they are under. The choice of antipsychotic medication is made jointly with the young person and their parents or carers, and healthcare professionals. Age-appropriate information is provided by prescribers to help with this and the likely benefits and possible side effects of each drug are discussed. The prescribing psychiatrist is free to change the dose and type of antipsychotic in response to the effectiveness and side effects, which is consistent with current guidelines. If a participant allocated to either the psychological intervention alone or antipsychotic medication alone group experiences a deterioration in their mental state, they are offered the option to move into the combined treatment arm and psychological intervention or antipsychotic medication is started. Participants stay in the study and continue to follow the schedule of assessments. In order to minimise burden participants are asked their preference on the venue for the assessment and are seen in their own home if preferred, unless there is a reason which would prevent this. During assessment and testing, breaks are provided to minimise possible fatigue or stress, and if indicated, can be spread over several days.

When is the study starting and how long is it expected to run for? March 2017 to June 2019

Who is funding the study? National Institute for Health Research (UK)

Who is the main contact?Mrs Melissa Pyle

Previous plain English summary:Background and study aimsPsychosis is a mental health problem that causes people to perceive or interpret things differently from those around them. Common symptoms of psychosis are unusual beliefs (delusions) and hallucinations (most often, hearing voices). Antipsychotics are the standard medication for these problems and are often often helpful but can have serious side effects. There is also evidence that talking therapies (such as cognitive behaviour therapy (CBT) or family intervention) can help reduce symptoms and prevent relapse. The guidelines suggest that treatment options should include the possibility of choice between CBT, antipsychotic medication or both. However, more research is needed to see how well psychological treatment works when used alone, compared with antipsychotic medication and compared with psychological treatment and antipsychotic medication combined. The first stage to better understanding what is most helpful is to conduct a small study to see if young people and their families want to take part in this kind of research and to find out what they think of taking part. This will show whether a larger study should be done and the best way to do it.

Who can participate? Patients aged 14-18 diagnosed with psychosis

What does the study involve? Participants are randomly allocated to one of three groups. Participants in the first group are treated with psychological therapy, which involves up to 30 sessions of CBT plus 6 sessions of family intervention (this is optional). Participants in the second group are treated with antipsychotic medication prescribed by the participant’s own psychiatrist. Participants in the third group are treated with a combination of psychological therapy and antipsychotic medication. All participants are also asked to attend four research assessments and physical health checks: at the first visit, then at 3, 6 and 12 months after the first visit. Participants who are recruited into the study after February 2018 are not seen for a research assessment and physical health check at 12 months because of the study end date.

What are the possible benefits and risks of participating? Each participant benefits from access to one or more currently recommended treatments for psychosis. The likelihood of risk from the treatments is minimal. The investigators have considerable experience of the treatments and assessments used in this study and are not aware of any risks to participants. While the risks are minimal there may be a risk of side effects from antipsychotic medication. Although this is a standard treatment for young people with psychosis there are side effects from antipsychotics. To address this risk, the antipsychotic medication is prescribed by the participant’s psychiatrist, based in the care team they are under. The choice of antipsychotic medication is made jointly with the young person and their parents or carers, and healthcare professionals. Age-appropriate information is provided by prescribers to help with this and the likely benefits and possible side effects of each drug are discussed. The prescribing psychiatrist is free to change the dose and type of antipsychotic in response to the effectiveness and side effects, which is consistent with current guidelines. If a participant allocated to either the psychological intervention alone or antipsychotic medication alone group experiences a deterioration in their mental state, they are offered the option to move into the combined treatment arm and psychological intervention or antipsychotic medication is started. Participants stay in the study and continue to follow the schedule of assessments. In order to minimise burden participants are asked their preference on the venue for the assessment and are seen in their own home if preferred, unless there is a reason which would prevent this. During assessment and testing, breaks are provided to minimise possible fatigue or stress, and if indicated, can be spread over several days.

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33209; HTA 15/31/04

Study information

Scientific title

A randomised controlled trial of antipsychotic medication in comparison to psychological intervention and a combined treatment in children and young people with first episode psychosis: a feasibility study

Acronym

MAPS

Study hypothesis

The aim of this study is to determine whether it is feasible to conduct a study to examine the effectiveness of a psychological intervention (Cognitive Behaviour Therapy plus family intervention), antipsychotic medication or a combination of both, in adolescents with first episode psychosis.

Ethics approval

North West – Greater Manchester East Research Ethics Committee, 06/02/2017, ref: 16/NW/0893

Condition

Intervention

Randomisation will be in the ratio 1:1:1 to the three groups and will be stratified by site and family contact (since participants who do not have regular contact with their families will not receive the family intervention components of psychological intervention, although they will still be included). Randomisation (at the individual level) will be independent and concealed, using randomised-permuted blocks of random size administered via a study-specific web-based system developed by the Clinical Trials Unit.

Participants will be randomly allocated to one of three treatment arms:1. Psychological Intervention alone: This will comprise of up to 30 sessions of individual Cognitive Behaviour Therapy (CBT) plus the option of up to six sessions of family intervention (FI) over a 6-month treatment window. 2. Antipsychotic medication alone: The antipsychotics (AP) will be selected by the participants own psychiatrist from their care team. The APs will be selected from those commonly used in the treatment of young people with psychosis, with dosages within recommended limits; the responsible consultant psychiatrists will choose the individual AP. The choice of antipsychotic medication should be made jointly with the young person and their parents or carers, and healthcare professionals. The psychiatrists will initiate the first dose of AP as soon as possible and will be encouraged to keep patients on their AP for a minimum of 12 weeks, and preferably for 26 weeks; however, they will be free to change dose and type of antipsychotic in response to monitoring of efficacy and adverse effects, which is consistent with current NICE guidelines.3. Combine psychological intervention and antipsychotic medication: a combination of both treatments as outlined above.

All participants will be invited to a research assessment and physical health check with a blind (independent) assessor. These will take place at baseline and then again at 3 months, 6 months and 12 months’ post randomisation. Participants who are recruited into the study after February 2018 will not be seen for a research assessment and physical health check at 12 months because of the study end date.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Current primary outcome measure as of 03/08/2018:As this is a feasibility trial, a single primary outcome is not meaningful and the key outcomes to inform a future trial are:1. Referral rates and recruitment rates, assessed at the end of the recruitment window in October 20182. Attendance at therapy sessions, compliance with medication and follow-up and questionnaire response rates, assessed at the end of the follow-up window in April 20193. Acceptability of treatment, measured using rates of drop-out from treatment at the end of the follow-up window by April 2019

Previous primary outcome measure:As this is a feasibility trial, a single primary outcome is not meaningful and the key outcomes to inform a future trial are:1. Referral rates and recruitment rates, assessed at the end of the recruitment window in June 20182. Attendance at therapy sessions, compliance with medication and follow-up and questionnaire response rates, assessed at the end of the follow-up window in December 20183. Acceptability of treatment, measured using rates of drop-out from treatment at the end of the follow-up window by December 2018

Secondary outcome measures

Current secondary outcome measures as of 03/08/2018:All secondary outcomes are being collected to determine their suitability for use in a subsequent trial, rather than to draw conclusions about safety or efficacy of treatments.

The proposed primary outcome measure for a subsequent definitive trial will be symptoms of psychosis and schizophrenia assessed using the Positive and Negative Syndrome Scale (PANSS), a commonly used outcome in psychosis trials, allowing comparison with wider evidence. The PANSS will be collected as a secondary outcome for this study and will be administered at baseline and then again at 3 months, 6 months and 12 months’ follow-up.

Other secondary outcomes include:1. Social/educational/occupational functioning, assessed using the First Episode Social Functioning Scale (FESFS) at baseline and then again at 3 months, 6 months and 12 months’ follow-up2. Self-rated recovery, assessed using the Questionnaire about the Process of Recovery (QPR) at baseline and then again at 3 months, 6 months and 12 months’ follow-up3. Dimensions of psychotic symptoms, assessed using the Specific Psychotic Experiences Questionnaire (SPEQ) at baseline and then again at 3 months, 6 months and 12 months’ follow-up4. Adverse effects (weight gain, sexual dysfunction, metabolic effects and extrapyramidal effects) assessed using the antipsychotic non-neurological side effects scale and a full physical health examination (weight, body mass index, waist circumference, blood pressure and fasting estimates of plasma glucose (FPG), HbA1c, lipids and serum prolactin levels) at baseline and then again at 3 months, 6 months and 12 months’ follow-up5. Common comorbidities, assessed using the Hospital Anxiety and Depression Scale (HADS), the Alcohol Use Disorder Identification Test (AUDIT), the Drug Abuse Screening Test (DAST) and autism spectrum conditions using the adult version of the Autism Spectrum Quotient (AQ-10) at baseline and then again at 3 months, 6 months and 12 months’ follow-up6. Basic data on health economics, including the health status questionnaire (EQ-5D) at baseline and then again at 3 months, 6 months and 12 months’ follow-up7. Hospital admissions and serious adverse events, recorded each time they occur over the duration of the study until the end of the follow-up window in December 20188. Dose of antipsychotic medication, measured using a review of patient notes at the end of the follow-up period in April 20199. Dose of psychological intervention, recorded at the end of therapy for each participant allocated to receive the psychological intervention; data will be available on this at the end of the follow-up window in April 2019

Previous secondary outcome measures:All secondary outcomes are being collected to determine their suitability for use in a subsequent trial, rather than to draw conclusions about safety or efficacy of treatments.

The proposed primary outcome measure for a subsequent definitive trial will be symptoms of psychosis and schizophrenia assessed using the Positive and Negative Syndrome Scale (PANSS), a commonly used outcome in psychosis trials, allowing comparison with wider evidence. The PANSS will be collected as a secondary outcome for this study and will be administered at baseline and then again at 3 months, 6 months and 12 months’ follow-up.

Other secondary outcomes include:1. Social/educational/occupational functioning, assessed using the First Episode Social Functioning Scale (FESFS) at baseline and then again at 3 months, 6 months and 12 months’ follow-up2. Self-rated recovery, assessed using the Questionnaire about the Process of Recovery (QPR) at baseline and then again at 3 months, 6 months and 12 months’ follow-up3. Dimensions of psychotic symptoms, assessed using the Specific Psychotic Experiences Questionnaire (SPEQ) at baseline and then again at 3 months, 6 months and 12 months’ follow-up4. Adverse effects (weight gain, sexual dysfunction, metabolic effects and extrapyramidal effects) assessed using the antipsychotic non-neurological side effects scale and a full physical health examination (weight, body mass index, waist circumference, blood pressure and fasting estimates of plasma glucose (FPG), HbA1c, lipids and serum prolactin levels) at baseline and then again at 3 months, 6 months and 12 months’ follow-up5. Common comorbidities, assessed using the Hospital Anxiety and Depression Scale (HADS), the Alcohol Use Disorder Identification Test (AUDIT), the Drug Abuse Screening Test (DAST) and autism spectrum conditions using the adult version of the Autism Spectrum Quotient (AQ-10) at baseline and then again at 3 months, 6 months and 12 months’ follow-up6. Basic data on health economics, including the health status questionnaire (EQ-5D) at baseline and then again at 3 months, 6 months and 12 months’ follow-up7. Hospital admissions and serious adverse events, recorded each time they occur over the duration of the study until the end of the follow-up window in December 20188. Dose of antipsychotic medication, measured using a review of patient notes at the end of the follow-up period in December 20189. Dose of psychological intervention, recorded at the end of therapy for each participant allocated to receive the psychological intervention; data will be available on this at the end of the follow-up window in December 2018

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant exclusion criteria

1. A primary diagnosis of alcohol/substance dependence *2. A diagnosis of moderate or severe learning disability * 3. A diagnosis of ICD-10 organic psychosis *4. Score 5+ on PANSS conceptual disorganisation / disorganised speech (since majority of participants will be randomised to a talking therapy, we require capacity to answer questions in an interview situation and engage in a conversation)5. Non-English speaking (since majority of participants will be randomised to a talking therapy)6. Received APs or structured PI within the last 3 months (to ensure treatment naivety)7. Immediate risk to self or others (to ensure appropriate safety considerations can be addressed)

* These exclusions are to ensure that the participant population are representative of young people with a primary problem of first episode psychosis

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/03/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/08/2018: The following changes have been made to the trial record:
1. The overall trial end date was changed from 28/02/2019 to 30/06/2019
2. The primary outcome measure has been updated
3. The secondary outcome measures have been updated
4. The recruitment end date was changed from 30/06/2018 to 31/10/2018
5. The plain English summary has been updated